Study of SXL01 in Patients With Metastatic Castration-Resistant Prostate Cancer (PROSTIRNA) (PROSTIRNA)
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|ClinicalTrials.gov Identifier: NCT02866916|
Recruitment Status : Not yet recruiting
First Posted : August 15, 2016
Last Update Posted : November 25, 2016
This is a single site, open-label, non-randomized, dose escalation phase I study designed to evaluate the safety, the tolerability and the Recommended Phase II Dose (RP2D) of SXL01, a synthetic small interfering ribonucleic acid (RNA) targeting the androgen receptor messenger RNA (mRNA), in patients with metastatic castration-resistant prostate cancer.
A standard method "3+3" will be used for dose escalation. A maximum of 30 patients will complete the dose-escalation phase of the study; 12 additional patients will be included at the RP2D in the expansion phase.
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Cancer, Castration-Resistant||Drug: SXL01||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of SXL01 in Patients With Metastatic Castration-Resistant Prostate Cancer|
|Study Start Date :||June 2017|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: Dose escalation
The standard method "3+3" will be used for dose escalation: the first 3 patients will be treated at level 1; consecutive cohorts of 3 to 6 patients will be treated with increasing doses of SXL01.
Treatment will be administered until patient experiences unacceptable toxicity, PSA raising, progressive disease and/or treatment is discontinued at the discretion of the investigator or withdrawal of consent.
Additional patients will be included at the Recommended Phase II Dose (RP2D) in the expansion phase.
- Incidence rate of Dose Limiting Toxicities (DLT) during the first cycle of treatment with SXL01. [ Time Frame: 25 months ]
- Characteristics of Dose Limiting Toxicities (DLT) during the first cycle of treatment with SXL01. [ Time Frame: 25 months ]
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 33 months ]Tolerability and safety will be assessed through recording of adverse events using National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) toxicity classification, monitoring biological parameters and vital signs measurement.
- Preliminary efficacy endpoint : rate of patients presenting Prostate Specific Antigen (PSA) progression defined using Prostate Cancer Clinical Trial Working Group 3 (PCWG3) [ Time Frame: 33 months ]
- Preliminary efficacy endpoint : rate of patients presenting clinical or radiological progression using Response Evaluation Criteria in Solid Tumours (RECIST) V1.1 as defined by PCWG3. [ Time Frame: 33 months ]
- Pharmacokinetics - SXL01 plasma concentration [ Time Frame: Cycle 1: pre-dose (T0) then 0.5, 3, 6, 24 hours post dose on day 1 ; T0 on days 4, 8, 15, 22. Subsequent cycles : before administration on day 1 (CXD1). The day of treatment discontinuation (CXDX) : 0.5, 1, 2, 24 hours post-dose. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866916
|Contact: Jean-Pierre DELORD, MD, PhD||+33 5 31 15 51 firstname.lastname@example.org|
|Institut Claudius Regaud||Not yet recruiting|
|Toulouse, France, 31059|
|Contact: Jean-Pierre DELORD, MD, PhD +33 53 15 51 00 email@example.com|
|Principal Investigator: Jean-Pierre DELORD, MD, PhD|